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临床试验/NCT06948409
NCT06948409进行中(未招募)不适用

The Choice of Neuromuscular Blockade Reversal Agent and Its Effects on Postoperative Urinary Retention: A Retrospective Cohort Study

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 70,000 人开始时间: 2025年6月8日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
70,000
试验地点
1
主要终点
PACU discharge delay due to POUR

研究概览

简要总结

In this single-center retrospective cohort study of adult patients who underwent surgery under general anesthesia at Beth Israel Deaconess Medical Center between September 2016 and January 2024, the association between the choice of neuromuscular blocking agent (NMBA) reversal strategy, comparing sugammadex with neostigmine (combined with a muscarinic antagonist), and postoperative urinary retention (POUR) will be evaluated. In secondary analyses, the effects of NMBA reversal strategy and POUR on costs of care and unplanned hospital visits will be analyzed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients
  • Non-urinary system surgery
  • General anesthesia
  • Use of rocuronium or vecuronium for neuromuscular blockade
  • Neuromuscular blockade reversal with sugammadex or neostigmine (with atropine and/or glycopyrrolate)
  • Postoperative admission to the post-anesthesia care unit (PACU)

排除标准

  • American Society of Anesthesiologists (ASA) physical status ≥ V
  • Emergency reversal with sugammadex (≥ 16 mg/kg of sugammadex)
  • Presence of foley or suprapubic catheter before or after the procedure
  • Prior history of bladder resection surgery
  • Observations with missing data for pre-specified confounding variables

结局指标

主要结局

PACU discharge delay due to POUR

时间窗: During the admission to the PACU (Perioperative, up to day 1)

The primary outcome, post-anesthesia care unit (PACU) discharge delay due to postoperative urinary (POUR), will be defined as a documented delay in PACU discharge due to the inability to void. The PACU nurses or physicians responsible for immediate postoperative care routinely document these delays. Documentation about delays is required before a patient is discharged from the PACU. Within the individual categories "renal", "urinary", and "other", the investigators will search through all free text entries related to urinary retention. The study team will perform this review, and potential misspellings or synonyms will be identified and accounted for during the review process. The final primary endpoint, PACU discharge delay due to POUR, will be binary, and the endpoint data will be reported as frequency (total number \[n\] and proportion \[%\]).

次要结局

  • Costs of care(During the patient's hospital stay (Through study completion, an average of 1-2 weeks))
  • Unplanned hospital visits(Within 7 days after surgery)
  • Time to PACU discharge readiness(During the admission to the PACU (Perioperative, up to day 1))
  • PACU length of stay(During the admission to the PACU (Perioperative, up to day 1))
  • Postoperative hospital length of stay(During the patient's hospital stay, defined as the time between surgery and day of discharge (Through study completion, an average of 1-2 weeks))
  • Urinary catheter use or straight catheterization(Within 3 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca J Wachtendorf, MD

Anesthesia Resident and Clinical Fellow, Co-Principal Investigator

Beth Israel Deaconess Medical Center

研究点 (1)

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